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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K904693
Device Name CUSTOMED CARDIOVASCULAR PACK
Applicant
CUSTOMED, INC.
CALL BOX 158
CAROLINA PUERTO RICO, 
Applicant Contact JOSE M NEGRON
Correspondent
CUSTOMED, INC.
CALL BOX 158
CAROLINA PUERTO RICO, 
Correspondent Contact JOSE M NEGRON
Regulation Number878.4370
Classification Product Code
KKX  
Date Received10/16/1990
Decision Date 01/02/1991
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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